Sr Director, QMS

Meet the team:

The Quality Management Systems (QMS) team at Dexcom plays a critical role in ensuring the integrity compliance and scalability of our global quality framework. As a strategic function within Global Quality the teamis responsible formaintaininga robust compliant and continuously improving QMS that supports product development manufacturing and post-market activities across all regions.

We partner cross-functionally with R&D Regulatory Affairs Manufacturing Supply Chain and Commercial teams to embed quality into every stage of the product lifecycle. Our mission is to enable innovation whilemaintainingthe highest standards of safety compliance and patient impact. As Dexcom continues to grow globally the QMS team ensures our processes evolve to meet increasingly complex regulatory requirements while staying efficient and scalable.

Where you come in:

As the Sr. Director of Quality Management Systems you will provide strategic leadership and oversight for Dexcoms global QMS ensuring it meets all applicable regulatory requirements (FDA ISO 13485 MDR and other international standards) while supporting business growth and innovation.

You will:

• Own and evolve the global QMS strategy ensuring alignment with corporateobjectivesand regulatory expectations

• Lead the design implementation and/orcontinuous improvement of key QMS processes including document control CAPAmetrics and analyticspartnershipmanagementaudit managementamongothers.

• Own thecorporateCAPA programensuring world class execution andperformance.

• Drive harmonization and standardization of quality processes across global sites and regions

• EstablishaQualityIntelligence program that focuses onrisks and developments across the medical device industry.

• OwnProjectManagementfor the Qualityorganization focusing on continuous improvement opportunities.

• Ensure inspection readiness at all timesandassistwithenterprise-level responses to regulatory inspections and audits

• Partner closely with Regulatory Affairs to interpret evolving global regulations and proactively integrate requirements into the QMS

• Build develop and lead a high-performingglobalQMS team

• Champion a culture of quality compliance and continuous improvement across the organization

• Leverage digital tools and data analytics to modernize and scale the QMS improving efficiency and visibility

• Provide executive-level reporting on QMS performance risks and improvement initiatives

What makes you successful:

You are a strategic forward-thinking quality leader who can balance compliance with agility in a fast-pacedinnovation-driven environment.

Leadership & Influence

• Proven ability to lead and scale global teams driving alignment across functions and geographies

• Strong executive presence with the ability to influence senior leadership and cross-functional stakeholders

Quality & Regulatory Expertise

• Deep knowledge of global QMS requirements including FDA 21 CFR Part 820 ISO 13485 EU MDR and other international standards

• Demonstrated success leading regulatory inspections and audits with positive outcomes

• Experience building or transforming QMS frameworks inacomplex global organization

Operational Excellence

• Track recordof implementing scalable efficient quality processes that support rapid business growth

• Strong systems mindset with experience driving digital transformation within QMS platforms (e.g.eQMSsystems)

• Data-driven decision-maker who uses metrics to drive continuous improvement

Strategic Mindset

• Ability toanticipateregulatory trendsandcorporate needsand proactively adapt systems and processes

• Strong business acumen with an understanding of howQuality enables innovation and market success

Collaboration & Communication

• Excellent cross-functional collaboration skills with the ability to translate complex regulatory requirements into practical business-friendly solutions

• Clear and compelling communicator capable of engaging audiences from frontline teams to executive leadership

Whatyoullget:

• A front row seat tolife changingCGM technology.Learn about our brave #dexcomwarriors community.

• Afull andcomprehensive benefitsprogram.

• Growth opportunities on a global scale.

• Access tocareer development through in-house learning programs and/orqualifiedtuition reimbursement.

• Anexcitingandinnovativeindustry-leading organizationcommitted to our employeescustomers and the communities we serve.

Travel Required:

• 15-25%

Experience and Education Requirements:

• Typically requires a Bachelorsdegree with 17 years of industryexperience

• 13 years of years of successfulleadership experience in relevant
  industry